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Novartis’ Scemblix approved by the EC for adults with chronic myeloid leukaemia

It is estimated that every year more than 6,300 people will be diagnosed with CML in Europe.

Novartis has announced that the European Commission (EC) has approved Scemblix – also known as asciminib – for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia (CML) in the chronic phase which has been previously treated with two or more tyrosine kinase inhibitors (TKIs).

Scemblix is the first CML treatment in Europe that works by specifically targeting the ABL myristoyl pocket, offering a reimagined treatment approach for patients who experience intolerance and/or resistance to currently available TKI therapies.

The EC approval for Scemblix follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June and the previous designation of Scemblix as an orphan drug – it is also applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein.

The approval is based on results from the pivotal phase 3 ASCEMBL trial, which showed a near doubling in major molecular response rate for patients treated with Scemblix versus Bosulif, with a more than three times lower discontinuation rate due to adverse reactions at the 24-week primary endpoint.

“Until now, patients with CML in Europe had oral TKI therapies with the same mechanism of action to turn to, and those experiencing significant side effects or resistance to these treatment options would often cycle between these very similar therapies, with little success in controlling their disease or improving their quality of life,” explained Dr Andreas Hochhaus, head of the department of haematology and medical oncology at Jena University Hospital in Germany.

He added: “The approval of Scemblix in Europe is a timely milestone that will help many patients find hope for the management of their CML.”

“Approval of Scemblix from the European Commission is a critical milestone to help bring this novel treatment to patients living with CML in Europe,” concluded Haseeb Ahmad, president, of Europe’s innovative medicines at Novartis. “Building on more than twenty years of innovation in CML, we are excited by the potential to once again transform the standard of care for more patients around the world.”

It is estimated that every year more than 6,300 people will be diagnosed with CML in Europe. While many patients will benefit from available TKI therapies, a significant proportion may experience intolerance or resistance to these treatments.